In a concerning series of events that have caught the attention of both the public and regulatory bodies, the Paragard IUD, a popular birth control device, has come under scrutiny for its alarming rate of breakages.
Spotlight on America, which has been closely monitoring the situation for over three years, uncovered significant issues with the device, culminating in a highly critical report from the Food and Drug Administration (FDA) following an inspection at the CooperSurgical manufacturing plant in Buffalo, N.Y.
The Disturbing Ordeal of Jennifer Davis
The story of Jennifer Davis puts a human face on the alarming statistics. Last year, Davis underwent a harrowing medical ordeal that began with a routine procedure to remove her Paragard IUD and ended with a hysterectomy. The device broke during the removal attempt, leading to pieces migrating dangerously close to her fallopian tubes and embedding in her uterus, risking severe complications like excessive bleeding, perforation, and infertility.
Davis described the experience of seeing the broken pieces of the device as “unnerving and shocking,” which led her to opt for a hysterectomy due to fear of further complications. Her story is not unique, as many women across the country have reported similar experiences with the Paragard IUD.
Surge in Breakage Reports
Data analysis from the FDA’s Adverse Event Reporting System shows a troubling trend, with 1,231 breakage reports in 2023 alone, the highest in a single year. Since tracking began, there have been over 6,000 complaints, 80% of which were considered serious. An analysis in 2022 revealed that Paragard devices break at nearly double the rate of other IUDs.
Despite these figures, and a warning label from 2019 acknowledging the risk of breakage, many women like Davis claim they were not adequately warned about these risks when choosing their method of birth control.
FDA and CooperSurgical: Actions and Inactions
In response to rising concerns, the FDA inspected CooperSurgical’s facility in 2022 and issued a stern report criticizing the company for its failure to adequately investigate the breakage complaints and to implement necessary corrective actions.
Despite this report, there has been little to no movement from CooperSurgical to address these issues, and the FDA’s subsequent actions appear limited. The agency conducted another inspection in February 2024, but the results have not been made public or available through Freedom of Information Act requests.
The Call for Accountability
Davis, having endured significant personal and financial costs due to the device’s failure — her medical bills amounted to nearly $60,000 — spoke out to help others understand the potential risks. She and many others affected by similar issues have urged the government and regulatory bodies to take stronger action.
The FDA maintains that Paragard is a safe device but has declined interviews regarding the breakage issues. Davis’s message to the FDA is clear: “Please address it. Acknowledge it. Tell people that this could break, this could cause major surgery, this could affect the rest of your life.”
As the situation unfolds, the call for transparency and action grows louder. Women like Jennifer Davis, supported by investigations like those conducted by Spotlight on America, are advocating for acknowledgment of the risks associated with Paragard and for measures to ensure such medical devices are safe and reliable.
The lack of response from CooperSurgical and the limited action from the FDA highlight the need for ongoing vigilance and advocacy to protect patient safety and ensure that the voices of those affected are heard and addressed.
Call Rueb Stoller Daniel About a Paragard IUD Lawsuit
If you or a loved one have been negatively impacted by Paragard IUD, contact the attorneys at Rueb Stoller Daniel at 1-866-CALL-RSD and see if you qualify to be part of the ongoing Paragard IUD Lawsuit.
Written by Angie Moreschi, Larry Deal, Andrea Nejman, Nathan Aaron for Spotlight on America. Published on April 2nd, 2024.
